Bio Solution Co., Ltd. Selected for U.S. FDA Entry Support Program for Two Allogeneic Chondrocyte Therapies

[Financial News] Bio Solution Co., Ltd. will receive government support in the process of entering the U.S. market with two allogeneic chondrocyte therapies currently under development.
Bio Solution Co., Ltd. announced on the 22nd that it had been selected as a recipient in the Global Regulatory Response Support category of the '2026 Second Pharmaceutical and Biotechnology Global Expansion Support Program,' organized by the Ministry of Health and Welfare (MOHW) and the Korea Health Industry Development Institute (KHIDI).
Through this selection, Bio Solution Co., Ltd. will receive government funding for regulatory consulting and administrative costs required to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) and respond to the regulatory review of its next-generation allogeneic chondrocyte therapies.
The supported products are CartiLoiD, which is undergoing Phase 1/2 clinical trials in Australia with the goal of restoring focal cartilage defects, and speroQure, an intra-articular injection currently undergoing Phase 1/2a clinical trials in Korea with the goal of controlling the structural progression of knee osteoarthritis.
Bio Solution Co., Ltd. plans to use the grant to analyze regulatory differences among the pipelines and review donor eligibility, Master Cell Bank (MCB) validation, chemistry, manufacturing, and controls (CMC), and whether the nonclinical and clinical data comply with FDA guidelines. It will also pursue the preparation of an electronic Common Technical Document (eCTD) for the U.S. IND submission and the establishment of the Standard for Exchange of Nonclinical Data (SEND).
The company will also leverage its experience responding to the FDA through its existing autologous chondrocyte therapy, CartiLife. CartiLife received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA after obtaining approval in Korea following Phase 3 trials and completing Phase 2 trials in the United States. Recently, the company held a Type C meeting with the FDA to discuss key endpoints for the U.S. Phase 3 trial, MRI-based structural assessment criteria, and long-term safety monitoring.
Bio Solution Co., Ltd. plans to prepare its U.S. IND application by applying the FDA regulatory experience accumulated through CartiLife to the development of allogeneic cell therapies.
Lee Jung-sun, CEO of Bio Solution Co., Ltd., said, "We will pursue U.S. IND approval for CartiLoiD and speroQure without setbacks by leveraging the U.S. FDA regulatory experience accumulated through CartiLife and our global CRO partnerships."

[email protected] Jeong Sang-hee Reporter